In the absence of any drug in the urine specimen, the colloidal gold-labeled antibody 122 Smith Road complex moves with the urine by capillary action to contact the immobilized drug conju- Kinderhook, NY 12106 gate. An antibody-antigen reaction occurs forming a visible line in the “test” area.

1.800.227.1243 The formation of two (2) or more visible lines (control and test lines) occurs when Outside the U.S.: +1.518.758.8158 the test is negative or below the cut-off for the drug. When a drug analyte is pre- www.abmc.com sent in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the antibody binding sites on the colloidal gold- labeled antibody complex. If a sufficient amount of drug analyte is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. The formation of a control line, and the absence of a test line is indicative of a preliminary positive result.

REAGENTS AND MATERIALS SUPPLIED

Each case of Rapid TOX Cup II contains: 1. Twenty five (25) Rapid TOX Cup II devices packaged in a foil pouch with a desiccant.

2. Product Instructions Product Instructions The Rapid TOX Cup II is a 200mL urine collection cup with a temperature strip at- INTENDED USE tached, and an area printed on the cup label where the date and donor identification

® may be written. Each test cup contains a multi-channeled insert. Each channel contain- Rapid TOX Cup II is an in vitro diagnostic point of collection drugs of abuse testing ing a test strip has immunoassays for up to four (4) different drugs of abuse. Each test device for professional use that incorporates collection and testing for the detection of strip is comprised of a membrane with two (2) attached absorbent pads and a pad drugs of abuse in human urine specimens. Rapid TOX Cup II uses one-step, lateral containing the immobilized colloidal gold-labeled antibody complex. The upper pad acts flow immunoassays for the simultaneous detection of up to fourteen (14) drugs of as a reservoir for the specimen after it migrates through the membrane. The test lines abuse. Rapid TOX Cup II may contain single assay and multiple assay test strips. The contain a carrier-drug conjugate for the individual analytes, dried on the membrane. The single assay test strips have the drug name labeled at the top of the strip and the multi- control line, containing goat anti-mouse IgG, is placed above the test lines on the mem- ple assay test strip has drug names printed on a separate label on the cup. All configu- brane. rations of this cup are covered by these product instructions. Rapid TOX Cup II is intended for use in the qualitative detection of the following drugs of abuse, or for speci- WARNINGS AND PRECAUTIONS men validity testing in a human urine specimen at the following levels: Test Level For in vitro diagnostic use. Compound Abbreviation (ng/mL) Follow proper handling and disposal procedures. 500 For professional use. (d- sulfate) AMP 1000 * While the Centers for Disease Control (CDC) has stated that “Universal precautions do () BAR 300 not apply to feces, nasal secretions, sputum, sweat, tears, urine, and vomitus unless they contain visible blood.”, the use of gloves is recommended for handling of all () BZO 300 specimens and is good hygienic practice. The Rapid TOX Cup II test device may be disposed of in a regular trash receptacle without any special handling. Buprenorphine BUP 12.5 150 Do not use if foil pouch seal is not intact (seal broken, tears, holes, etc.). (benzoylecgonine) COC 300 * Do not use if beyond the expiration date printed on the pouch. The expiration date is MDMA ((+/-) 3,4-methylenedioxy-) 500 MDMA (Ecstasy) 1000 formatted as YYYY/MM, e.g. 2016/01 means the kits should not be used after the end of January, 2016. Methadone MTD 300 STORAGE 500 ((+)methamphetamine HCl) MET 1000 The Rapid TOX Cup II test device should be stored at room temperature (59° to 86°F 300 Opiates (-3-b-D-glucuronide) OPI or 15° to 30°C) or refrigerated (36° to 46°F or 2° to 8°C). If refrigerated, allow test device 2000 * to warm up to room temperature before conducting any testing. Oxycodone OXY 100 SPECIMEN COLLECTION AND HANDLING

Phencyclidine ( HCl) PCP 25 * Use fresh urine specimens. Urine specimens do not require any special handling or Propoxyphene PPX 300 pretreatment. It is best to test urine specimens immediately after collection. If necessary, urine specimens may be refrigerated at 36° to 46°F (2° to 8°C) for two (2) THC/ (11-nor-∆9-THC-9-carboxylic-acid) THC 50 * days or frozen at -4°F (-20°C) or colder for longer periods. If refrigerated, allow the specimen to warm up to room temperature before conducting any testing. Tricyclic (nortriptyline) TCA 1000 Instruct the donor to provide an adequate urine specimen.

A temperature strip is attached to the Rapid TOX Cup II. For fresh urine specimens a *Screening cut-off concentrations recommended by Substance Abuse Mental Health Services Admini- stration (SAMHSA). reading between 90-100°F (32-38°C) is considered a viable specimen. The temperature should be read within four (4) minutes and is indicated by a green dot. If The barbiturates (BAR), benzodiazepines (BZO) and tricyclic antidepressants (TCA) the temperature strip remains black, erroneous results may occur. Results are stable for tests will yield preliminary positive results when barbiturates, benzodiazepines or four (4) hours. tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturates, benzodiazepines, or tricyclic Use of gloves is recommended for handling of all specimens and is good hygienic prac- antidepressants in human urine. Certain foods or medicines may interfere with tests for tice. The Rapid TOX Cup II test device may be disposed of in a regular trash recepta- barbiturates, benzodiazepines, and tricyclic antidepressants and may cause preliminary cle. Avoid contact with skin. Avoid cross-contamination of urine specimens by using a positive results. new container for each urine specimen.

PROCEDURE

SUMMARY AND EXPLANATION 1. Verify the foil pouch is intact. Verify the product is within the expiration date as

indicated on the pouch. Rapid TOX Cup II incorporates competitive immunoassays utilizing highly specific 2. Provide the donor with the Rapid TOX Cup II device and device cover. reactions between antibodies and antigens for the simultaneous detection of 3. Remove the Rapid TOX Cup II from the foil pouch just prior to collection. amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, MDMA 4. Instruct donor to provide adequate specimen volume. Urine level must be above the (ecstasy), methadone, methamphetamines, opiates, oxycodone, phencyclidine, minimum fill line printed on the Rapid TOX Cup II. propoxyphene, THC (cannabinoids), and tricyclic antidepressants in human urine. 5. Upon receipt of the specimen and within four (4) minutes, read the temperature strip to ensure it is between 90 – 100° F (32-38°C). PRINCIPLES OF THE TEST 6. The test strips in the Rapid TOX Cup II will begin running once urine is introduced into the cup. Keep the Rapid TOX Cup II in an upright position or place on a flat Each Rapid TOX Cup II test device contains test strips for drugs of abuse that are one- surface. step immunoassays. The specifically labeled drug (drug conjugate) competes for anti- 8. Allow the test to proceed undisturbed until all reddish-purple control lines appear and body binding sites with drugs or metabolites that may be present in the urine specimen. the test background clears. The control line is the uppermost line in each channel in the The test strip consists of a membrane strip with an immobilized drug conjugate. A colloi- test area. Once all control lines are visible the tests are ready to be interpreted, typically dal gold-labeled antibody (mouse or rabbit) complex is dried at one end of the mem- this occurs in three to five (3-5) minutes. brane. A control line, comprised of a different antibody/antigen reaction (Goat Anti- 9. Read results as explained under Interpretation of Results. Mouse or Goat Anti-Rabbit), is present on the membrane strip. The control line is not influenced by the presence or absence of a drug analyte in the urine specimen, and therefore, it should be present in all reactions.

Page 1 INTERPRETATION OF RESULTS - DRUG TEST PERFORMANCE CHARACTERISTICS

The test results may be interpreted once the control line(s) have formed and the back- SPECIFICITY ground on the test strip(s) has cleared. This will occur in approximately three to five Interference and cross reactivity studies were performed by testing the drug analytes in (3-5) minutes. The test results are determined by the presence or absence of the test the Rapid TOX Cup II test device with various other drugs. Below is the list of drugs and control lines, therefore color blindness will not affect reading the results of the test. that will give a preliminary positive result at or above the concentration stated. All of the The test results are stable for up to four (4) hours. following drugs were added to normal, drug-free urine. Note: The drugs listed are

preliminary positive for only the drug test specified. Test Valid The device control line is the uppermost line appearing in each test channel. Before DRUG TEST CONCENTRATION Amphetamines 500 ng/mL reading the test result lines, verify that the control line has formed in each test channel, d-Amphetamine 500 indicating that the test is valid. If the control line does not appear in each test channel, d, I-amphetamine 500 the test is invalid and the test results must not be used. The test should be repeated I-Amphetamine 20,000 using a new Rapid TOX Cup II device. The intensity of the control lines may vary. Any (a, a-Dimethylphenethylamine) 1250 line, without regard to intensity or size, is a line. (+/-) - Methylenedioxyamphetamine (MDA) 750 Amphetamines 1000 ng/mL Test Invalid d-Amphetamine 1000 If no control line appears after approximately ten (10) minutes, consider the test invalid. d, I-amphetamine 1000 Repeat the test using another Rapid TOX Cup II device. I-Amphetamine 20,000 Phentermine (a, a-Dimethylphenethylamine) 1250 Negative (+/-) - Methylenedioxyamphetamine (MDA) 750 A NEGATIVE result for a single drug in a multiple assay test strip is the presence of a Barbiturates reddish-purple line adjacent to the drug name. A negative result for a single assay test (5,5-Diallybarbituric Acid) 300 (Amytal; 5-Ethyl-5-Isoamylbarbituric Acid) 1000 strip is the presence of two (2) reddish-purple lines, the upper control line and the lower 150 test line. The intensity of the test lines may vary. Any line, without regard to intensity (Barbitone; 5,5-Diethlybarbituric Acid; Veronal) 1250 or size, is a line. 750 Butalbital 300 Preliminary Positive Butethal 500 A PRELIMINARY POSITIVE result for a single drug in a multiple assay test strip is the 5,5 Diphenylhydantoin () 2500 absence of a line adjacent to the drug name. A preliminary positive result for a single (Nembutal) 300 assay test strip is the presence of only one reddish-purple line (the control line) and no 1500 test line. (Quinalbarbitone) 150 75 Buprenorphine 12.5 CONTROL LINE/ TEST LINE INTERPRETATION Buprenorphine glucuronide 10 10,000 Control Line Test Line for Each Drug Interpretation Hydrocodone 25,000 50,000 No control line present No test line present Invalid test Morphine 25,000 Nalmefene 75,000 No control line present Test line present Invalid test Naltrexone 100

Control line present Test line present Negative Norbuprenorphine 10,000 Norbuphrenorphine glucuronide 1500 Control line present No test line present Preliminary positive Benzodiazepines Alpha-hydroxyalprazolam 10,000 75 Examples of Results: 400 150 Multiple assay test strip Single assay test strip 100 300 Test Valid Test Invalid - Test Valid + Test Invalid 100 - + No control line No control line Desalkylfurazepam 500 Desmethyldiazepam 100 C Control Control C N-desmethylflunitrazepam 100

Diazepam 100

Drug 1 Drug 1 500 T Drug 2 Drug 2 T 150 Drug 3 Drug 3 2-Hydroxyethylflurazepam 5000 Drug 4 Drug 4 4-Hydroxynordiazepam 4000 (+/-) 2200 Example: Drug 3 in the multiple assay test strip is preliminary positive Lorazepam glucuronide 250 500 Note: It was determined in a study that there is no contamination of a urine sample from any 75 component of the Rapid TOX Cup II, the reagent strips or the reagents in the strip that causes any Norchlordiazepoxide 500 interference with the test results during re-analysis by the confirmation laboratory of the sample after Nordiazepam 150 nine (9) days storage at room temperature. Both negative and preliminary positive samples were Oxazepam 300 tested in this study at one (1), three (3), five (5), and nine (9) days post initial analysis. Negative results Oxazepam glucuronide 750 were obtained on all negative samples and preliminary positive results were obtained on all positive samples, showing no interference after one (1), three (3), five (5) and nine (9) days. Therefore, a Sulindac 7500 sample that is transported to a laboratory for confirmation will not be affected due to storage of the 100 sample in the Rapid TOX Cup II during transport and need not be transferred to another container. Temazepam glucuronide 75 1500 QUALITY CONTROL Cocaine 150 ng/mL Benzoylecgonine 150 A procedural control (the control line [C]) is built into each test strip, indicating that the Cocaethylene 150 reagents on the device are present and functioning properly. Cocaine (Ecgonine Methyl Ester Benzoate) 100 Metoclopramide 80,000 For laboratory use it is good laboratory practice to use positive and negative controls to Procaine (Novocaine) 75,000 ensure proper test performance. Follow federal, state and local requirements for QC Cocaine 300 ng/mL testing. Control specimens are commercially available. Positive and negative controls Benzoylecgonine 300 Cocaethylene 300 should be used: 1) prior to using a new lot/shipment of test devices, 2) if the product has Cocaine (Ecgonine Methyl Ester Benzoate) 100 been stored outside the recommended storage conditions, or 3) as determined by your Metoclopramide 80,000 organization’s protocol. Procaine (Novocaine) 75,000 MDMA (Ecstasy) 500 ng/mL LIMITATIONS OF PROCEDURE (+/-) 3,4-methlylenedioxy-methamphetamine (MDMA) 500 +/- Methamphetamine 500 Rapid TOX Cup II is designed for use with human urine only. + Methamphetamine 500

Rapid TOX Cup II provides only a preliminary qualitative test result. Use a more (+/-) 3,4-Methylene-n-ethylmethamphetamine (MDEA) 20,000 Procaine 50,000 specific alternate quantitative analytical method to obtain a confirmed analytical Ranitidine 40,000 result. Liquid chromatography Mass spectrometry (tandem MS) LC-MS/MS or gas 20,000 chromatography/mass spectrometry (GC/MS) are the preferred confirmatory MDMA (Ecstasy) 1000 ng/mL (1) method . HPLC may be used as the confirmatory method for tricyclic antidepressants. (+/-) 3,4-methlylenedioxy-methamphetamine (MDMA) 1000 Use best judgment to any Rapid TOX Cup II test result, particularly when preliminary +/- Methamphetamine 1000 positive results are obtained(2). + Methamphetamine 500 (+/-) 3,4-Methylene-n-ethylmethamphetamine (MDEA) 20,000 Other substances and/or factors not listed may interfere with the test and cause Procaine 60,000 erroneous results, such as adulterants, procedural errors or cross reactivity with other Ranitidine 50,000 drugs or agents. Refer to the Performance Characteristics section for more information. Trimethobenzamide 20,000 Page 2 (Continued from previous page) THC/ Cannabinoids () Methadone Cannabinol Benzotropine Methane sulfonate 30,000 ** 25,000 50,000 11-Hydroxy-D9-Tetrahydrocannabinol 5000 Disopyramide 60,000 11-Nor-D8-Tetrahydrocannabinol-9 Carboxylic Acid 50 Isopropamide 500 11-Nor-D9-Tetrahydrocannabinol-9 Carboxylic Acid 50 (+/-) Methadone 300 11-Nor-D9-Tetrahydrocannabinol-9 Carboxylic Acid Glucuronide 2500 (-)-á-Methadol 300 D8-Tetrahydrocannabinol 20,000 (-)-á-Acetylmethadol (LAAM) 2500 D9-Tetrahydrocannabinol 20,000 Procyclidine 50,000 ** Efavirenz is the generic drug found in some HIV treatment medications. Research sources Suxibuzone 25,000 have indicated that it is highly possible false positive results for THC may be observed in Methamphetamines 500 ng/mL patients taking medications which may include Efavirenz. (+/-)- 3,4-Methylenedioxy-n-ethylamphetamine (MDEA) 20,000 Tricyclic Antidepressants Procaïne (Novocaïne) 60,000 1000 Trimethobenzamide 20,000 75,000 +/- Methamphetamine 500 Cyclobenzaprine 8000 (+/-)- Methamphetamine 725 50,000 Ranitidine (Zantac) 50,000 1000 (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) 725 5000 Methamphetamines 1000 ng/mL 1000 (+/-) 3,4-Methylenedioxy-n-ethylamphetamine (MDEA) 20,000 Norclomipramine 2500 Procaine (Novocaine) 60,000 Nordoxepin 500 Trimethobenzamide 20,000 Nortriptyline 1000 +/- Methamphetamine 1000 12,500 + Methamphetamine 500 Protriptyline 2000 Ranitidine (Zantac) 50,000 3000 (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) 1000 Opiates 300 ng/mL 6-Acetylmorphine 500 Codeine 100 EFFECTS OF pH AND SPECIFIC GRAVITY Eserine (Physostigmine) 15,000 Ethylmorphine 100 A series of experiments were conducted to evaluate the effects of pH on the reactivity of Heroin (Diacetylmorphine) 500 the Rapid TOX Cup II drug tests. Normal urine was adjusted to various pH levels by Hydromorphone 2000 the addition of NaOH or HCI. Exogenous target drug or metabolite was then added to Hydrocodone 1250 these pH-adjusted specimens to give a final concentration of the target cut-off level for Morphine 300 that assay. A pH range of 3.0 to 12.0 was investigated. In all cases pH was found not to Morphine-3-b-D-Glucuronide 75 affect the ability of the Rapid TOX Cup II to detect the targeted level of drug or metabo- Nalorphine 500 lite for that assay. Norcodeine 35,000 Additional experiments determined that specific gravity did not affect the ability of Rapid Oxycodone 50,000 TOX Cup II drug tests to detect the targeted drug or metabolite at the target cut-off (Paramorphine) 13,000 level for that assay. Normal urine, specific gravity of 1.020, were diluted to produce Opiates 2000 ng/mL urine with lower specific gravity values. Exogenous drug or metabolite was then added 6-Acetylmorphine 1000 Codeine 800 to these specimens to give a final concentration of the target cut-off for that assay. An Ethylmorphine 400 aqueous solution (specific gravity of 1.000) of the drug or metabolite with a concentra- Heroin (Diacetylmorphine) 10,000 tion of the target cut-off was also evaluated. In all cases, over the specific gravity range Hydromorphone 2000 of 1.005 to 1.020 preliminary positive results were obtained by Rapid TOX Cup II drug Hydrocodone 5000 tests. Specific gravity has little or no effect on the reactivity of Rapid TOX Cup II drugs Morphine 1600 of abuse tests. Morphine-3-b-D-Glucuronide 2000 Oxycodone 75,000 Thebaine (Paramorphine) 26,000 SENSITIVITY Oxycodone 6-Acetylcodeine Single assay: 11,000 Multi assay: 3000 Known concentrations of drug were added to normal, drug-free urine. Ten (10) 6-Acetylmorphine Single assay: 22,500 Multi assay: 750 determinations were made at each serial dilution of the single analyte. Sensitivity is Codeine Single assay: 900 Multi assay: 300 defined as that concentration which produced preliminary positive responses in all ten Dihydrocodeine Single assay: 325 Multi assay: 325 (10) replicates. Hydromorphone Single assay: 3,500 Multi assay: 1250 Hydrocodone Single assay: 75 Multi assay: 20 AVERAGE AVERAGE Morphine Single assay: 3,000 Multi assay: 450 CONCENTRATION CONCENTRATION Noroxycodone 50,000 DRUG DRUG (ng/mL) (ng/mL) Oxycodone 100 Oxymorphone Single assay: 200 Multi assay: 50 500 500 Amphetamines Methamphetamines Thebaine 25,000 1000 1000 Phencyclidine (PCP) 300 Phencyclidine 25 Barbiturates 300 Opiates 4-Hydroxy phencyclidine 90 2000 Phencyclidine Morpholine 625 100,000 Benzodiazepines 300 Oxycodone 100 Rapid TOX Cup II PCP also detects high concentrations of the cough suppressant . In young children, dextromethorphan overdoses may produce a preliminary positive result for PCP. However, adults ingesting therapeutic dosages of dextromethorphan should not produce a preliminary Buprenorphine 12.5 Phencyclidine 25 positive result. Propoxyphene 150 Propoxyphene 300 Cocaine Propoxyphene 300 Norpropoxyphene 200 300

500 MDMA (Ecstasy) THC/Cannabinoids 50 1000 Tricyclic Methadone 300 1000 Antidepressants

Page 3 SUMMARY (Summary chart continued)

No immunoassay that produces a single response in relation to the presence of multiple Drug Concentration in ng/mL Results # Pos./10 components in a mixture can reliably quantify the concentration of these components. (For example, the Rapid TOX Cup II barbiturates test detects several barbiturates. 25 0/10 Attempts to establish semi-quantitative concentrations are not recommended. The sensitivity of this test to detect barbiturates is at an average concentration of 38 3/10 300 ng/mL). THC/Cannabinoids 50 10/10 Drug Concentration in ng/mL Results # Pos./10 250 3/10 75 10/10 Amphetamines 375 2/10 500 0/10 500 ng/mL 500 10/10 625 10/10 750 2/10 500 0/10 Tricyclic Antidepressants Amphetamines 750 2/10 1000 10/10 1000 ng/mL 1000 10/10 1250 10/10 1250 10/10 150 0/10 225 2/10 Barbiturates 300 10/10

375 10/10 150 0/10 225 2/10 Benzodiazepines 300 10/10 375 10/10 5 0/10 10 2/10 Buprenorphine 12.5 10/10 15 10/10 75 0/10 Cocaine 113 2/10 150 ng/mL 150 10/10 187 10/10 150 0/10 Cocaine 225 3/10 300 ng/mL 300 10/10 375 10/10 250 0/10 MDMA 375 3/10 500 ng/mL 500 10/10 625 10/10 500 0/10 MDMA 750 2/10 1000 ng/mL 1000 10/10 1250 10/10 150 1/10 225 3/10 Methadone 300 10/10 375 10/10 250 0/10 Methamphetamines 375 1/10 500 ng/mL 500 10/10 615 10/10 500 0/10 Methamphetamines 750 3/10 1000 ng/mL 1000 10/10 1250 10/10 150 0/10 Opiates 225 2/10 300 ng/mL 300 10/10 375 10/10 1000 0/10 Opiates 1250 3/10 2000 ng/mL 2000 10/10 2500 10/10 50 0/10 75 3/10 Oxycodone 100 10/10 125 10/10 13 0/10 19 3/10 Phencyclidine 25 10/10 37 10/10 150 0/10 225 3/10 Propoxyphene 300 10/10 375 10/10

Page 4 ACCURACY

Contrived samples of known GC/MS results were tested on the Rapid TOX Cup II at the levels specified below.

Near Near Negative Positive Be- High Low Between tween the Positive Percent Negative 50% below cutoff and Greater than Drug Name Agree- Nega- Less than the cutoff 50% above 50% above ment Rapid TOX tive 50% of the and the cut- the cutoff the cutoff Cup II Re- No Drug cutoff con- off concen- concentra- concentra- sult Present centration tration tion tion OPI POSITIVE 0 0 28 98 98 100% 2000ng/mL NEGATIVE 939 48 67 0 0 97.4% OPI POSITIVE 0 0 25 96 96 100% 300 ng/mL NEGATIVE 432 48 71 0 0 95.7% METH POSITIVE 0 0 26 98 97 100% 1000 ng/mL NEGATIVE 926 47 71 0 0 97.6% METH POSITIVE 0 0 29 96 96 100% 500 ng/mL NEGATIVE 96 48 67 0 0 87.9% COC POSITIVE 0 0 29 97 96 100% 300 ng/mL NEGATIVE 1295 49 69 0 0 98.0% COC POSITIVE 0 0 26 96 96 100% 150 ng/mL NEGATIVE 432 48 70 0 0 95.5% AMP POSITIVE 0 0 17 104 104 100.0% 1000 ng/mL NEGATIVE 1272 52 87 0 0 98.8% AMP POSITIVE 0 0 29 96 96 100 500 ng/mL NEGATIVE 432 48 67 0 0 95.0% MDMA POSITIVE 0 0 18 106 106 100% 1000 ng/mL NEGATIVE 925 53 88 0 0 98.3% MDMA POSITIVE 0 0 27 96 96 100% 500 ng/mL NEGATIVE 96 48 69 0 0 88.8% THC POSITIVE 0 0 26 104 104 100.0% 50 ng/mL NEGATIVE 2039 52 78 0 0 98.8% OXY POSITIVE 0 0 30 102 102 100% 100 ng/mL NEGATIVE 1372 51 72 0 0 98.0% BZO POSITIVE 0 0 13 106 106 100% 300 ng/mL NEGATIVE 2033 53 93 0 0 99.4% BAR POSITIVE 0 0 23 102 102 100% 300 ng/mL NEGATIVE 1279 51 79 0 0 98.4% PPX POSITIVE 0 0 28 104 104 100.0% 300 ng/mL NEGATIVE 1272 52 76 0 0 98.0% PCP POSITIVE 0 0 28 104 104 100% 25 ng/mL NEGATIVE 1272 52 76 0 0 98.0% MTD POSITIVE 0 0 33 106 106 100.0% 300 ng/mL NEGATIVE 2031 53 73 0 0 98.5% BUP POSITIVE 0 0 26 106 106 100.0% 12.5 ng/mL NEGATIVE 1264 53 80 0 0 98.2% TCA POSITIVE 0 0 22 102 102 100% 1000 ng/mL NEGATIVE 1276 51 80 0 0 98.5% REPRODUCIBILITY

Reproducibility studies were carried out using contrived urine specimens. Each speci- men was contrived to a specific concentration compared to drug cutoff. Each specimen was tested by approximately fifty (50) consumers in one day. (Reproducibility continued) Drug Concentration Concentration # Results Precision Drug Concentration Concentration # Results Precision to Cutoff in ng/mL to Cutoff in ng/mL

AMP 0.5 254 48 NEG 36/48 COC 300 0.5 49 NEG 35/49 500 (75.00%) 136 (71.43%) 0.75 49 NEG 34/49 0.75 389 48 NEG 31/48 187 (69.39%) (64.58%) 1.25 49 POS 49/49 1.25 650 48 POS 48/48 364 (100.00%) (100.00%) 1.5 48 POS 48/48 1.5 757 48 POS 48/48 402 (100.00%) (100.00%) MDMA 0.5 48 NEG 38/48 AMP 0.5 280 52 NEG 45/52 500 250 (79.17%) 1000 (86.54%) 0.75 48 NEG 31/48 0.75 818 52 NEG 42/52 375 (64.58%) (80.77%)

1.25 48 POS 48/48 1.25 1299 52 POS 52/52 (100.00%) (100.00%) 625

1.5 48 POS 48/48 1.5 1474 52 POS 52/52 (100.00%) (100.00%) 750

MDMA 1000 0.5 53 NEG 47/53 BAR 0.5 157 51 NEG 44/51 (88.68%) (86.27%) 500

0.75 270 51 NEG 35/51 0.75 53 NEG 41/63 (68.63%) 750 (77.36%)

1.25 323 51 POS 51/51 1.25 53 POS 53/53 (100.00%) 1250 (100.00%)

1.5 687 51 POS 51/51 1.5 53 POS 53/53 (100.00%) 1500 (100.00%)

BUP 0.5 4.2 53 NEG 46/53 METH 0.5 48 NEG 37/48 (86.79%) 500 250 (77.08%)

0.75 5.0 53 NEG 34/53 0.75 48 NEG 30/48 (64.15%) 375 (62.50%)

1.25 10 53 POS 53/53 1.25 48 POS 48/48 (100.00%) 625 (100.00%)

1.5 12 53 POS 53/53 1.5 48 POS 48/48 (100.00%) 750 (100.00%)

BZO 0.5 149 53 NEG 50/53 METH 1000 0.5 48 NEG 38/48 (94.34%) 500 (79.17%)

0.75 248 53 NEG 43/53 0.75 49 NEG 33/49 (81.13%) 750 (67.25%)

1.25 391 53 POS 53/53 1.25 49 POS 49/49 (100.00%) 1250 (100.00%)

1.5 438 53 POS 53/53 1.5 49 POS 49/49 (100.00%) 1500 (100.00%)

COC 0.5 48 NEG 38/48 MTD 0.5 53 NEG 38/53 150 66 (79.17%) 150 (71.70%) 0.75 48 NEG 32/48 0.75 53 NEG 35/53 96 (66.67%) 225 (66.04%) 1.25 48 POS 48/48 1.25 53 POS 53/53 158 (100.00%) 375 (100.00%) 1.5 48 POS 48/48 193 (100.00%) 1.5 53 POS 53/53 450 (100.00%)

Page 6 (Reproducibility continued) CROSSREACTIVITY

Drug Concentration Concentration # Results Precision The following drugs are not detected by Rapid TOX Cup II at concentrations less than to Cutoff in ng/mL 100,000 ng/mL unless otherwise specified:

Acebutolol OPI 0.5 48 NEG 37/48 Acetaldehyde 300 150 (77.08%) Acetaminophen (4-Acetamidophenol; N-Acetyl-paminophenol) Acetazolamide 0.75 48 NEG 34/48 3-(α-acetonylbenzyl)-4-hydroxycoumarin (Warfarin) 225 (70.83%) Acetophenetidin Acetopromazine 1.25 48 POS 48/48 N-Acetyl-L-cysteine 375 (100.00%) 6-Acetylmorphine (except OPI & OXY) N-Acetylprocainamide (Acecainide) 1.5 48 POS 48/48 Acetylsalicylic Acid (Aspirin; 2-Acetoxybenzoic Acid) 450 (100.00%) Albumin, standard Albuterol Allobarbital (5,5-Diallybarbituric Acid) (except BAR) OPI 0.5 47 NEG 34/47 Allopurinol (4-Hydroxypyrazole (3,4-) Pyrimidine) 2000 1000 (72.34%) Alpha- hydroxyriazolam* Alprazolam (except BZO) 0.75 48 NEG 33/48 1500 (68.75%) (Adamantan-1-amine) Amcinonide 1.25 49 POS 49/49 (+) Amethopterin (4-Amino-10-methylfolic acid; Methotrexate; Methylaminopterin) Amikacin 2500 (100.00%) p-Aminobenzoic Acid 1.5 49 POS 49/49 7-Aminoclonazepam 3000 (100.00%) 7-Aminoflunitrazepam DL-Aminoglutethimide OXY 0.5 51 NEG 39/51 7-Aminonitrazepam 50 (76.47%) Amiodarone Amitriptyline (except TCA) Ammonium Chloride 0.75 51 NEG 33/51 Amobarbital (amytal;5-Ethyl-5- Isoamyl barbituric Acid) (except BAR) 75 (64.71) Amoxetine 1.25 51 POS 51/51 Amphotericin B 125 (100.00%) D-Amphetamine (except AMP) DL-Amphetamine (except AMP) 1.5 51 POS 51/51 L-Amphetamine (except AMP) (100.00%) Ampicillin 150 D-Amygdalin Aniline PCP 0.5 52 NEG 41/52 Antipyrine (Phenazone) 12.5 (78.85%) Aprobarbital (except BAR) 0.75 52 NEG 35/52 18.75 (67.31%) Ariprazole (-) Arterenol [(-)] L-Ascorbic Acid 1.25 52 POS 52/52 ASP-PHE-Methyl-Ester (Aspartame) 31.25 (100.00%) D-Aspartic Acid DL-Aspartic Acid 1.5 52 POS 52/52 L-Aspartic Acid 37.5 (100.00%) Astemizole Atomoxetine PPX 0.5 52 NEG 40/52 (Tropinetropate) (76.92%) 150 Atrovastin Azathioprine 0.75 52 NEG 36/52 225 (69.23%) Barbital (Barbitone;5,5-Diethylbarbituric acid; Veronal) (except BAR) Barbituric Acid (2,4,6- Trihydroxypyrimidine; Malonylurea) 1.25 52 POS 52/52 Beclomethasone 375 (100.00%) Beclomethasone Dipropionate Bendroflumethiazide Benzidine (4,4 Diaminobiphenyl) 1.5 52 POS 52/52 Benicar 450 (100.00%) Benzylic Acid β-diethylaminoethyl ester Benzocaine (Ethyl-p-Aminobenzoate) TCA 0.5 51 NEG 41/51 Benzoic Acid 500 (80.39%) Benzonatate Benzoylecgonine (except COC) (α-dimethylphenethylamine) 0.75 51 NEG 39/51 Benzthiazide (76.47%) 750 Benztropine Methane sulfonate (Benztropine Mesylate) 1.25 51 POS 51/51 Benzyl 1250 (100.00%) Benzylamine 1.5 51 POS 51/51 Berberine Betamethasone 1500 (100.00%) Bilirubin Bisacodyl THC 0.5 52 NEG 41/52 Bromazepam (except BZO) 25 (78.85%) 2-Bromo-α-ergocryptine ( mesylate) (+) Brompheniramine (Dexbrompheniramine) 0.75 52 NEG 37/52 (+/-) Brompheniramine 37.5 (71.15%) Bumetanide Bupivacaine Buprenorphine (except BUP) 1.25 52 POS 52/52 HCL (100.00%) 62.5 Butabarbital (except BAR) 1.5 52 POS 52/52 Butalbital (except BAR) 75 (100.00%) Butethal (except BAR) Butacaine 2-ButynoicAcid Ethyl Ester (Ethyl-2-Butynoate) Butyrophenone (1,3,7-Trimethylxanthine) (Continued from previous page) Dimercaprol (2,3-Dimercaptopropanol) 11-Hydroxy-∆9-Tetrahydrocannabinol* (except Morphine (except BUP,OPI & OXY) (+/-) Camphor 4-Dimethylaminoantipyrine (Aminopyrine) THC) Morphine-3-β-D-Glucuronide (except OPI) 1,1-Dimethylbiguanide (Metformin) 5-Hydroxytryptamine (Serotonin) Mupirocin Cannabinol (except THC) Dimethyl isosorbide 3-Hydroxytyramine Nabumetone Canrenoic Acid Dimethyl Sulfoxide (DMSO) (Atarax) Captopril 1,3-Dimethyluric Acid L-Hyoscyamine Nafcillin 1,7-Dimethylxanthine Ibuprofen Nalburphine Carbamyl-β-methylcholine-chloride (Bethanechol Diphenhydramine (except MTD) Irbesartan Nalidixic Acid Chloride) 5,5-Diphenylhydantoin (Phenytoin) (except BAR) -4-Acetic acid Nalmefene (except BUP) Carboplatin Dipyridamole Imipramine (except TCA) Nalorphine (except OPI) (s)-(-)-Carbidopa Dipyrone Indapamide Naloxone Disopyramide (except MTD) Indole-3-Acetic acid Naltrexone (except BUP) Divalproex Indole-3-Butyric Acid Cefaclor DL-Indole-3-Lactic Acid α-Naphthalene Acetic Acid Cefadroxil Doxepin (except TCA) Indomethacin β-Naphthalene Acetic Acid Cefotaxime Doxycycline Interferon α-Naphthol Cefoxitin Ipratropium Neomycin Sulfate Ceftriaxone Iproniazid Nialamide Cefuroxime Ecgonine Isonicotinic Acid (Pyridine-4-Carboxylic Acid) Nicotic Acid () Cephalexin Ecgonine Methyl Ester Isonicotinic Acid Hydrazide Cephaloridine Efavirenz Isopropamide (except MTD) Nitrazepam (except BZO) Cephradine (Cefradine) Emetine (+)Isoproterenol Nitrofurantoin Cetirizine Enalapril (-)Isoproterenol α- (-)-ψEphedrine (+/-)Isoproterenol 11-Nor-∆8-Tetrahydrocannabinol-9-Carboxylic Chloramphenicol (Chloromycetin) (+)-ψ- Acid* (except THC) Chlorcyclizine (+)Ephedrine Kanamycin 11-Nor-∆9-Tetrahydrocannabinol-9-Carboxylic Chlordiazepoxide (except BZO) (+/-)Ephedrine Acid* (except THC) 2-(p-Chlorophenoxy)-2-Methylpropionic Acid Ethyl (-)Epinephrine Ketoprofen 11-Nor-∆9-THC-9-Carboxylic Acid Glucuronide* Ester (Clofibrate) (+/-)Epinephrine Kynurenic Acid (except THC) Chloroquine Erythromycin Norclomipramine (except TCA) Chlorothiazide Escitalopram Lamotrigine Norocaine Chlorotrianisene Eserine (Physostigmine) (except OPI) Lanoprazole Norcodeine (except OPI) (+)Chlorpheniramine Estazolam (except BZO) Lansoprazole Nordoxepin (except TCA) (+/-)Chlorpheniramine ß-Estradiol Nordiazepam (except BZO) Estriol Levothyroxine Norethindrone Chlorpropamide Estrone Lidocaine Norfloxacin Estrone-β-D-Glucuronide Linoleic Acid-Conjugated (CLA), Gamma, Alpha; DL- Chlorthalidone Estrone-3-Sulfate Eicosapentanoic, docahexaenoic acid; omega 369 Normorphine Chlorzoxazone (5-Chloro-2-Hydroxybenzoxazole) Ethacrynic Acid Lisinopril d-Norpropoxyphene (except PPX) Ethambutol Lithium Carbonate Nortriptyline (except TCA) Cimetidine Ethamivan (N,N-Diethylvanillamide) Loperamide Noscapine Cinchonidine Ethanol, Standard Loratadine Nylidrin Cinoxacin Ethopropazine (+/-)Lorazepam (except BZO) Olmesartan Ciprofloxacin Ethosuxuximide (2-Ethyl-2-Methylsuccinimide) Lormetazepam (except BZO) Omeprazole Citalopram* 2-Ethyl –2-Phenylmalonamide Lysergic Acid Diethylamide (LSD) Orotic Acid (Uracil-6-Carboxylic Acid) Citalopram Hydrobromide* Glycol Mebendazole Orphenadrine Clarithromycin Ethylenediaminetetraacetic Acid (EDTA) Meclizine Oxalic Acid (Ethanedioic Acid) Clemastine 2-Ethylidine-1,5-Dimethyl-3,3-diphenylpyrolidine Meclofenamic Acid Oxaprozin Ethylmorphine* (except OPI & OXY) Oxazepam (except BZO) Clindamycin 17-α-Ethynylestradiol Clindamycin Phosphate Etodolac Melanin Oxybutynin Chloride Clobazam (except BZO) Etoposide Meloxicam Oxycodone (except OPI &OXY) Clobetasone Butyrate Ezetimibe Melphalan Clomipramine (except TCA) Famotidine (-) Oxyphenbutazone Clonazepam (except BZO) Felodipine Meperidine Oxyprenolol Oxypurinol Clorazepate (except BZO) Fenoprofen [(+/-)-2-(3-Phenoxyphenyl) Propionic Paclitaxel Clorazepate Dipotassium Acid] Pancuronium Bromide Cloxacillin Fentanyl* 6-Mercaptopurine Pantoprazole Ferrous Sulfate Mersalyl Acid Papaverine ethylene (except COC) Fexophenadine (3,4,5-Trimethoxyphenyethylamine) Pargyline Cocaine (Ecgonine Methyl Ester Benzoate) (except DL- Paroxetine HCL COC) Flurbiprofen Metaproterenol Phenazopyridine Codeine (Desferrioxamine Mesylate) (except BUP, [(-)-m-Hydroxyphenylpropanolamine] Phencyclidine Morpholine (except PCP) OPI & OXY) Flunisolide (+/-) Methadone (except MTD) Penicillin G () Flunitrazepam (except BZO) (+) Methamphetamine (Methylamphetamine; d- Pentachlorophenol Cortisone Desoxyephedrine) (except MDMA & MET) Pentobarbital (Nembutal) (except BAR) β-Cortol Flurandrenolide (+/-) Methamphetamine (except MDMA & MET) Pentoxifylline (Trental) Creatinine (except BZO) , Absolute Pentylenetetrazole Cromolyn (Cromoglycic Acid) Flurbiprofen Phencyclidine (except PCP) Cyclobenzaprine (except TCA) Formaldehyde Methazolamide Cyclophosphamide Methotrimeprazine p-Phenylenediamine Cyclosporin A Phenelzine Cyproheptadine (except TCA) Gemfibrozil Methoxamine Phenformin Dantrolene Gentamicin Sulfate (S)-6-Methoxy-α-Methyl-2-Napthalene Acetic Acid Deferoxamine Mesylate Gentisic Acid (Naproxen) Phenobarbital (except BAR) Glucose R-(-)-Deprenyl () (D)-(+)-Glucose (Dextrose) 5-Methoxytryptamine Phenolphthalein Desipramine (except TCA) Glibenclamide 3-Methoxytyramine (Thiodiphenylamine) N- (Normethylclozapine) Griseofulvin 2-Methyl-3-(3,4-dihydroxyphenyl)-DL-Alanine Phenoxymethyl Penicillinic Acid (Penicillin V) Desmethyldiazepam (except BZO) Guaiacol Glyceryl Ether 2-Methyl-3-(3,4-dihydroxypheyl)-L-Alanine Phentermine (α,α-Dimethylphenethylamine) Desoximetasone 3,3’-Methylene-bis-(4-Hydroxycoumarin) (except AMP) Dexamethasone Guanethidine (Dicumarol) Dexbrompheniramine Methylene Blue DL- Dextromethorphan Halcinonide (+/-) 3,4-Methylenedioxyamphetamine (MDA) L-Phenylalanine 4,4’-Diaminophenyl Sulfone (Dapsone) (except AMP) Phenylbutazone (except BZO) Hemoglobin (+/-) 3,4-Methylenedioxymethamphetamine L- Diazoxide Heroin (Diacetylmorphine)* (except OPI) (MDMA) (except MET & MDMA) (+/-)-α-Phenylethylamine (Methylene Chloride) Hexachlorocyclohexane (+/-) 3,4-methylenedioxy-n-ethylamphetamine (α-Methyl benzylamine) Dichlorphenamide Hexachlorophene (MDEA) (except MET & MDMA) β-Phenylethylamine Diclofenac 1-Methylhistamine (R)-(+)-α-Phenylethylamine Dicyclomine Hippuric Acid 6 α-Methyl-17 α-Hydroxyprogesterone (+/-) (PPA) Dieldrin Histamine [2 (4-Imidazolyl) Ethylamine] (Medroxyprogesterone) Phenylosamide Diethyldithiocarbamic Acid DL-Homatropine 6 α-Methylprednisolone (Medrol) Phthalic Acid (1,2-Benzenedicarboxylic Acid) N,N-Diethylnicotinamide (Niacin Diethylamide; Hydralazine (1-Hydrazinophthalazine) (Ritalin) Nikethamide) (1S,9R)- β-Hydrastine Methyl Salicylate Pilocarpine Diflorasone Diacetate Hydrochlorothiazide Methyl Viologen (Gramoxone; Paraquat Dichloride) Diflucortolone pivalate Hydrocodone (except BUP,OPI& OXY) Meticrane Pinacidil Diflunisal Hydrocortisone Metoclopramide (except BUP & COC) Digitoxin Hydroflumethiazide (+/-) Pioglitazone Digoxin (1,2 β-Hydroxydigitoxin) Hydromorphone (except OPI & OXY) Metronidazole L-Pipecolic Acid DL-3-4 Dihydroxymandelic Acid Hydroxocobalamin Mexiletine (except AMP) Pipemidic Acid DL-3-4 Dihydroxyphenyl Glycol O-Hydroxyhippuric Acid Piroxicam 3,4 Dihydroxyphenylacetic Acid 5-Hydroxyindole-3-Acetic Acid Potassium Chloride (2,3-Dihydroxypropyl) (Dyphylline) 5-Hydroxy-2-indole-2-Carboxylic Acid Milrinone Potassium Iodide Diltiazem 4-Hydroxy-3-Methoxyphenylacetic Acid (Homovan- Minaprine Diltiazem-cardizem nilic Acid) Minocycline Dimenhydrinate 4-Hydroxy Phencyclidine (except PCP) (except BZO) Prednisolone (1-Dehydrocortisol) Page 8 (continued from previous page) Trouble Shooting Tips Prednisone (Dihydrocortisone) cis-Tramadol 5-Pregnen-3β-OL-20-one Trans-2-Phenylcyclopropylamine (EPI ; ) (-mine) Potential Failure Potential Cause of Failure Corrective/Preventive Prilocaine Tramadol HCl Actions Primaquine (2-Desoxyphenobarbital) Triamcinolone (Fluoxiprednisolone) One or more of the test strips The test strips may not all begin If one or more of the test strips Proadifen Triamterene Probenecid [p-(Dipropylsulfamoy) Triazolam* (except BZO) fails to flow immediately to flow at the same time fail to flow after 1 minute, Benzoic Acid] Trichlormethiazide agitate the cup on a flat surface Procainamide Trichloroacetic acid It is not uncommon for strips to for a few seconds Procaine (Novocaine) (except COC, MDMA & 2,2,2 Trichloroethanol flow at different rates MET) All test strips should yield results within the 3 to 5 minute Procyclidine (except MTD) DL-Trihexyphenidyl Promazine (except TCA) Trimethobenzamide (except MDMA & time period MET) Propionyl promazine Trimethoprim Do not turn the cup upside d-Propoxyphene (except PPX) 3,5,5-Trimethyloxazolidine-2-4dione down during the testing period DL- (Trimethadione) 2-Propylpentanoic Acid (Valproic Acid) Trimipramine (except TCA) One or more of the test strips Insufficient sample Ensure sample is above the Protein Triprolidine fail to flow Sample is below the minimum fill minimum fill line labeled on the Pyridoxine DL-Tropic Acid Protriptyline (except TCA) Tropine line cup d- Tryptamine [3-(2-Aminoethyl) Indole] Pyridine-2-AldoximeMethochloride (Pralidoxime DL-Tryptophan (3 β-Indolylalanine; (+/-)-α- Test results are washed out Vigorously shaking the cup or Avoid excessive agitation or Chloride) Amino-3-Indolepropionic Acid) or test line(s) appears turning the cup upside down will turning the cup upside down Pyrilamine (Mepyramine) d-Tubocurarine Chloride smeared flood the test strip(s) Quinapril (4-Hydroxyphenethylamine) If agitation is necessary, lightly DL- agitate the cup on a flat surface Quinine Urea (Carbamide) Quinolinic Acid (2,3-Pyridinedicarboxylic Acid) Uric Acid for a few seconds Ramipril Vancomycin Ranitidine (Zantac) (except MDMA & MET) (+/-) Cup has leaked during Lid was loosely placed on the Ensure that the lid is placed on Rescinnamine Venlafaxine (except PCP) shipment for confirmation cup prior to shipping the cup and tightened appropri- Reserpine Vincamine ately prior to shipping Ribavirin Vitamins Riboflavin Warfarin The Control Line(s) does not Flooding of the test strip(s) by Test is considered invalid appear after 10 minutes excessive agitation or turning the Rosiglitazone Rosuvastatin Zearalenone cup upside down Repeat the test (Albuterol) Salicylamide (2-Hydroxybenzamide) Zomepirac Avoid excessive agitation or Salicylic Acid (2-Hydroxybenzoic Acid) turning the cup upside down (-) (Hyoscine) Secobarbital (Quinalbarbitone) (except BAR) *tested at 10,000 ng/mL If agitation is necessary, lightly Sertraline Simvastatin agitate the cup on a flat surface Sodium Chloride for a few seconds Sodium Formate (+/-) The Control Line(s) does not Insufficient sample Test is considered invalid appear after 10 minutes Sample below the minimum fill Succinylcholine Chloride line Repeat the test Sulfamethazine Sulfamethoxazole Sulfanilamide (p-Aminobenzenesulfonamide) Ensure sample is above the Sulfathiazole minimum fill line labeled on the Sulfisoxazole cup Sulindac (except BZO) (+/-) Color blindness Result and control lines are Color differentiation is not Suxibuzone (except MTD) (For analyte result interpreta- colored required to interpret the test Talbutal (except BAR) tion) results Tannic Acid Temazepam (except BZO) Once the control lines have Tenoxicam formed the results are read by Terazonin the appearance or lack of a line Terazosin HCl Questionable results Physical degradation of device, Follow product instructions for improper storage, opening pack- correct product storage, Terfenadine Tetracycline age too soon prior to testing, handling and result Tetraethyl Thiuram Disulfide (Disulfiram) attempting to read test results interpretation ∆8-Tetrahydrocannabinol (except THC) outside of result interpretation ∆9-Tetrahydrocannabinol (except THC) window Tetrahydrozoline Thebaine (Paramorphine) (except OPI & OXY) Questionable results or Specimen adulteration Upon receipt of the specimen Theobromine (3,7-Dimethylxanthine) excessive invalid results and within four (4) minutes, Theophylline (1,3-Dimethylxanthine) read the temperature strip to Thiamine (Aneurine) Thimerosal (Sodium Ethylmercurithiosalicylate) ensure it is between 90 – 100° F (32-38°C) cis-Thiothixene (5-Methly-2-Isopropylphenol) Tobramycin Questionable results/ non- Incorrect or lack of specimen For the most reliable confirma- Tolazamide confirmation of preliminary confirmation testing tion results, confirm by GC/MS Tolbutamide positive results at limit of detection levels Tolmetin

Page 9 BIBLIOGRAPHY

1. Urine Testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986. 2. R. C. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed.,3Biomedical Publications, Davis Ca., 1982. 3. Federal Register, Department of Health and Human Services Mandatory Guidelines for Workplace Drug Testing Program, 59, 110, 22918-29931 (1994). 4. Stability of drugs of abuse in urine samples stored at –20°C. S.Dugan, et. Al. J.Anal. Tox. 18 (7) 391-396 (1994). 5. Long-term stability of abused drugs and anti-abuse chemotherapeutical agents stored at –20°C., D.E .Moody, et.al., J. Anal Tox. 23 (6) 535-540 (1999). 6. CDC (1987) Universal Precautions for Prevention of Transmission of HIV and Other Bloodborne Infections. MMWR 1988,37:377-388.

Rapid TOX Cup II was developed and is manufactured by American Bio Medica Corporation. Customer Service/ Technical Support: 1.800.227.1243 / Outside the U.S.: +1.518.758.8158. Website: www.abmc.com Rapid TOX Cup II is covered by U.S Patent No. 7,507,373 & 8,206,661; with additional patents pending

ABMC hereby warranties that its products covered under these Product Instructions will be free from defects in workmanship and materials at the time of sale. ABMC shall only be responsible for direct damages that may result from such defect in workmanship or materials. Test results should be confirmed by an accepted reference method such as GC/MS.

American Bio Medica Corporation 122 Smith Road Kinderhook, NY 12106 Tel: +1.518.758.8158 Fax: +1.518.758.8171 E-mail: [email protected]

©2015. All rights reserved. American Bio Medica Corporation. The Rapid TOX Cup II logo is a trademark, and Rapid TOX Cup and the American Bio Medica Corporation logo are registered trademarks of American Bio Medica Corporation. 06-RLB-834

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